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Biopharmaceutical Engineering/ CQV professional with over 20 years of experience. Strong Project Manager with ability to manage multiple projects and teams. Leverages design and start-up experience with new Biopharmaceutical manufacturing facilities and process systems. Leverages Engineering, Manufacturing, Commissioning, Validation, and Utility experience in support of Biopharmaceutical manufacturing.

  • Experience in managing the execution of the capital engineering strategy to support the Engineering, Procurement, Construction, & Management (EPCM) of multiple Cell and Gene Therapy Manufacturing Facilities.

  • Skilled with driving and coordinating key technical project deliverables involving feasibility, conceptual design, basic design, detailed design, construction oversight, and operational readiness.

  • Strong budget, contract, and timeline management skills

  • Provide design, CQV, and operational oversight for Manufacturing support Facilities and areas.

  • Supports the development, execution, and updating of the Integrated Project Schedule (IPS): from conceptual design, detail design, construction, operational readiness, commissioning, validation, and full release for manufacturing.

  • Experienced in the development of manufacturing facility design, equipment URS, Specification/ Quotation, purchase, delivery, installation, and commissioning.

  • Adeptly executes solutions to technical problems using innovative approaches and leading-edge technologies.

  • Lead cross functional team in the development of the Project Operational Readiness requirements and implement into the Integrated Project Schedule.

  • Leverages engineering standards in supporting detail design of manufacturing facility.

  • Experience leading in the execution process risk assessment throughout the project.

  • Support the development of the Commissioning and Validation Master Plans for the project.

  • Responsible for the management of the development, design, planning, execution, review and final sign-off of CQV protocols.

  • Experience in Developing/ implementing the Tech Transfer of products into MFG Facilities.

  • Applies Quality by Design principles/ experience which aligns with FDA, ICH, and ISPE guidelines.

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